Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Lim
Recalled January 14, 2026 · FDA recall D-0248-2026 · Alembic Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. · FDA Class III
Sold at
US Nationwide and PR.
Description
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Product
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Manufacturer(s)
Alembic Pharmaceuticals Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →